Reported Dec 14, 2022 · Terminated
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation…
Medacta USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medacta Usa Inc · 3973 Delp St · Memphis, TN · 38118-6110
Is this the product you have?
- NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
- Lot codes and dates
- Document Reference Code 99.81NEXTAR.12US (for US market only)
- Revision NumbersRev.02 and previous
- Amount recalled
- 14 units
Where it was sold
Why it was recalled
A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.
This product could cause temporary or reversible health problems — stop using it.
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